BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE EXPANDER

    MDR report key: 24757884 · Received April 1, 2026

    Report

    Report Number
    MW5186266
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 11, 2026
    Report Date
    March 30, 2026
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I (45 YEAR OLD FEMALE) WAS DIAGNOSED WITH BREAST CANCER, AND A SINGLE (RIGHT SIDE) MASTECTOMY WAS PERFORMED (B)(6) 2026, WITH IMMEDIATE PLACEMENT OF A TISSUE EXPANDER (13X13CM BREAST 475CC STERILE ARTOURA MENTOR P6.8CM HIGH PROFILE ROUND LATEX FREE - SN/(B)(6), MANUFACTURED BY J&J - MENTOR CORP (B)(4), LOT NUMBER 2076443), WHICH WAS FILLED WITH 300 CC SALINE. ON (B)(6) 2026, THE EXPANDER WAS FILLED WITH AN ADDITIONAL 80 CC OF SALINE. ON (B)(6) 2026, JP DRAIN OUTPUT INCREASED FROM APPROX. 32 CC THE DAY PRIOR, TO 180 CC. DRAIN OUTPUT ON (B)(6) 2026 WAS 95 CC, AND THE BREAST WAS VISIBLY SHRUNKEN AND DEFLATED. AFTER CONSULTATION WITH PLASTIC SURGERY ON (B)(6) 2026, IT WAS DETERMINED THAT THE EXPANDER HAD RUPTURED AND WAS LEAKING. THE EXPANDER WAS SURGICALLY REMOVED, AND A NEW EXPANDER PLACED, ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811620 TISSUE EXPANDER TISSUE EXPANDER AND ACCESSORIES LCJ MENTOR TEXAS LP 2076443

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other ACETAMINOPHEN| ATENOLOL| FLONASE| IBUPROFEN| SPIRONOLACTONE| TRETINOIN